Pharmaceutical Quality Risk Management: FDA & ICH Q9 Guide
Quality Risk Management for New Products, Processes, Equipment, Facilities, Technology Transfer and Scale-Up Introducing a new pharmaceutical product, manufacturing process, equipment, facility modification, technology transfer, scale-up activity, or process change can create significant quality risks. A change that appears technically simple may affect: Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Material attributes Process capability … Read more